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Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

Primary Purpose

Kidney Calculi

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ureteroscopy
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy

Exclusion Criteria:

  • age < 18 years
  • pregnancy status
  • ureteral stone
  • preoperative hydronephrosis
  • indwelling nephrostomy tube
  • planning bilateral ureteroscopy or subsequent staged ureteroscopy
  • solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater)
  • variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction

Sites / Locations

  • University of California Los AngelesRecruiting
  • University of California DavisRecruiting
  • University of California San DiegoRecruiting
  • Indiana University Health Physicians UrologyRecruiting
  • Brigham and Women's HospitalRecruiting
  • Penn State HealthRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of MontrealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ureteral stent group

No ureteral stent group

Arm Description

A ureteral stent will be placed after ureteroscopy.

A ureteral stent will not be placed after ureteroscopy.

Outcomes

Primary Outcome Measures

Total number of complications
Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization

Secondary Outcome Measures

PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a
This survey assesses self-reported consequences of pain on relevant aspects of one's life, including engagement with social, cognitive, emotional, physical, and recreational activities. There are 6 questions on the survey. The survey score uses at T-score metric with a mean of 50 and a standard deviation of 10 in a referent population. A higher score denotes greater pain interference in one's life.
WISQOL (Wisconsin Stone Quality of Life Questionnaire)
This is a disease specific quality-of-life instrument designed to assess the impact on patients of stones in the urinary tract. The survey is a 28-item instrument with a 5-point LIkert scale for each item. There are a total of 140 points total, and a difference of 10 points can be considered clinically significant.
Cumulative opiate morphine equivalent dosing (MED)
This will be the calculated morphine equivalent dosage of all opiate medications that are prescribed after surgery to follow-up at 5-10 days.
% return to work
This is the number of participants that have returned to work at the time of follow-up at 5-10 days divided by the total participants in the group.
Number of participants with symptomatic urinary tract infection (UTI)
This will be defined as a urine culture positivity (50,000 cfu/mL or more) with urinary symptoms.
Number of participants with abnormal imaging findings
Hydronephrosis, hematoma, urinoma on routine postop imaging

Full Information

First Posted
February 24, 2019
Last Updated
July 20, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Université de Montréal, University of California, Davis, University of California, San Diego, Indiana University, Brigham and Women's Hospital, Penn State Health, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03855787
Brief Title
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Official Title
Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
March 11, 2025 (Anticipated)
Study Completion Date
November 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Université de Montréal, University of California, Davis, University of California, San Diego, Indiana University, Brigham and Women's Hospital, Penn State Health, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.
Detailed Description
Kidney stones affect 9% individuals within the United States, and the prevalence is increasing. Over the last few decades, ureteroscopy has become the most commonly performed stone procedure. However the complication rate after ureteroscopy is not insignificant. Reducing morbidity after ureteroscopy would improve patient outcomes and reduce health care utilization. A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after surgery. The rationale for utilizing stents is to prevent urinary obstruction from edema or stone fragments. On the other hand, stents cause hematuria, pain, and lower urinary tract symptoms. Additionally, stent-related symptoms are often misdiagnosed as urinary tract infections leading to unnecessary antibiotic use. The clinical utility of ureteral stents after ureteroscopy has not been well studied, specifically a stone located in the kidney. Prior studies on stent-less ureteroscopic procedures have focused on treatment of ureteral stones and not stones located in the kidney, have had restrictive inclusion and exclusion criteria, are primarily from single center institutions, and most being performed ~15 years ago. Surgical techniques and device innovations have changed the procedure since that time. To date, there have been only 2 studies that included stone located in the kidney showing no difference in unplanned hospital revisits, however both combined analyses with ureteral stones and selection bias was an issue for both studies. In addition, there is a lack of studies assessing opiate use, impact of quality of life with stent placement, and loss of work related to stent placement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Calculi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ureteral stent group
Arm Type
Active Comparator
Arm Description
A ureteral stent will be placed after ureteroscopy.
Arm Title
No ureteral stent group
Arm Type
Active Comparator
Arm Description
A ureteral stent will not be placed after ureteroscopy.
Intervention Type
Procedure
Intervention Name(s)
Ureteroscopy
Other Intervention Name(s)
Flexible ureteroscopy
Intervention Description
Ureteroscopy for 1.5cm or less renal stones.
Primary Outcome Measure Information:
Title
Total number of complications
Description
Total number of complications - Defined as ER visits related to procedure, unanticipated provider visit, and hospitalization
Time Frame
30 days after ureteroscopy
Secondary Outcome Measure Information:
Title
PROMIS (Patient-Reported Outcomes Measurement Information System) form 6a
Description
This survey assesses self-reported consequences of pain on relevant aspects of one's life, including engagement with social, cognitive, emotional, physical, and recreational activities. There are 6 questions on the survey. The survey score uses at T-score metric with a mean of 50 and a standard deviation of 10 in a referent population. A higher score denotes greater pain interference in one's life.
Time Frame
baseline to 5-10 days after ureteroscopy
Title
WISQOL (Wisconsin Stone Quality of Life Questionnaire)
Description
This is a disease specific quality-of-life instrument designed to assess the impact on patients of stones in the urinary tract. The survey is a 28-item instrument with a 5-point LIkert scale for each item. There are a total of 140 points total, and a difference of 10 points can be considered clinically significant.
Time Frame
baseline to 5-10 days after ureteroscopy
Title
Cumulative opiate morphine equivalent dosing (MED)
Description
This will be the calculated morphine equivalent dosage of all opiate medications that are prescribed after surgery to follow-up at 5-10 days.
Time Frame
baseline to 5-10 days after ureteroscopy
Title
% return to work
Description
This is the number of participants that have returned to work at the time of follow-up at 5-10 days divided by the total participants in the group.
Time Frame
5-10 days after ureteroscopy
Title
Number of participants with symptomatic urinary tract infection (UTI)
Description
This will be defined as a urine culture positivity (50,000 cfu/mL or more) with urinary symptoms.
Time Frame
Baseline 5-10 days after ureteroscopy
Title
Number of participants with abnormal imaging findings
Description
Hydronephrosis, hematoma, urinoma on routine postop imaging
Time Frame
4-8 weeks after ureteroscopy

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: nonobstructing renal stone 1.5cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing ureteroscopy Exclusion Criteria: age < 18 years pregnancy status ureteral stone preoperative hydronephrosis indwelling nephrostomy tube planning bilateral ureteroscopy or subsequent staged ureteroscopy solitary kidney or eGFR <60 mL/min (CKD stage 3 or greater) variant anatomy including horseshoe kidney, pelvic kidney, prior urinary tract reconstruction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Hsi, MD
Phone
615-343-2036
Email
ryan.hsi@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Hsi, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kymora Scotland, MD
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Canvasser, MD
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Bechis, MD
Facility Name
Indiana University Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelino Rivera, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel A Wollin
Facility Name
Penn State Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Knoedler, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Hsi, MD
Facility Name
University of Montreal
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naeem Bhojani

12. IPD Sharing Statement

Plan to Share IPD
No

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Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial

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